Advice only versus advice and a physiotherapy programme for acute traumatic anterior shoulder dislocation: the ARTISAN RCT.

Background: The extra benefit of a programme of physiotherapy in addition to advice alone, following first-time traumatic shoulder dislocation, is uncertain. We compared the clinical and cost-effectiveness of a single session of advice with a single session of advice and a programme of physiotherapy. Objective: The primary objective was to quantify and draw inferences about observed differences in the Oxford Shoulder Instability Score between the trial treatment groups 6 months post randomisation, in adults with a first-time traumatic shoulder dislocation. Design: A pragmatic, multicentre, superiority, randomised controlled trial with embedded qualitative study. Setting: Forty-one hospitals in the UK NHS. Participants: Adults with a radiologically confirmed first-time traumatic anterior shoulder dislocation, being managed non-operatively. People with neurovascular complications or bilateral dislocations, and those unable to adhere to trial procedures or unable to attend physiotherapy within 6 weeks of injury, or who had previously been randomised, were excluded. Interventions: All participants received the same initial shoulder examination followed by advice to aid self-management, lasting up to 1 hour and administered by a physiotherapist (control). Participants randomised to receive an additional programme of physiotherapy were offered sessions lasting for up to 30 minutes, over a maximum duration of 4 months from the date of randomisation (intervention). Main outcome measures: The primary outcome measure was the Oxford Shoulder Instability Score. This is a self-completed outcome measure containing 12 questions (0-4 points each), with possible scores from 0 (worst function) to 48 (best function). Measurements were collected at 6 weeks, 3 months, 6 months and 12 months by postal questionnaire; 6 months was the primary outcome time point. The primary health outcome for economic evaluation was the quality-adjusted life-year, in accordance with National Institute of Health and Care Excellence guidelines. Results: Between 14 November 2018 and 14 March 2022, 482 participants were randomised to advice (n = 240) or advice and a programme of physiotherapy (n = 242). Participants were 34% female, with a mean age of 45 years, and treatment arms were balanced at baseline. There was not a statistically significant difference in the primary outcome between advice only and advice plus a programme of physiotherapy at 6 months for the primary intention-to-treat adjusted analysis (favours physiotherapy: 1.5, 95% confidence interval -0.3 to 3.5) or at earlier 3-month and 6-week time points on the Oxford Shoulder Instability Score (0-48; higher scores indicate better function). The probability of physiotherapy being cost-effective at a willingness-to-pay threshold of £30,000 was 0.95. Conclusions: We found little difference in the primary outcome or other secondary outcomes. Advice with additional physiotherapy sessions was found likely to be cost-effective. However, small imprecise incremental costs and quality-adjusted life-years raise questions on whether it is the best use of scarce physiotherapy resources given current service demands. Limitations: Loss to follow-up was 27%; however, the observed standard deviation was much smaller than anticipated. These changes in parameters reduced the number of participants required to observe the planned target difference of four points. Our post hoc sensitivity analysis, accounting for missing data, gives similar results. Future work: Further research should be directed towards optimising self-management strategies. Study registration: This study is registered as ISRCTN63184243. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/167/56) and is published in full in Health Technology Assessment; Vol. 28, No. 22. See the NIHR Funding and Awards website for further award information.

The shoulder dislocates (comes out of its socket joint) when the upper end of the arm bone is forced out during an injury. This common problem occurs mostly in men in their 20s and women aged over 80. After the bone is put back in its socket, most people are managed with physiotherapy. In the United Kingdom, once the bone is back in its socket, there is a range of physiotherapy provision: some hospitals offer advice, and some offer advice and a course of additional physiotherapy sessions. We compared advice alone to advice and physiotherapy for people who had a shoulder that had come out of its joint for the first time. Physiotherapy advice and additional sessions included education about the injury and exercises to move and strengthen the shoulder. When we started this project, this was the first time these two treatments had been compared. Our aim was to compare what activities the two groups could do 6 months after injury via a questionnaire. We also compared quality of life and the cost of rehabilitation at 6 weeks, 3 months, 6 months and 12 months after injury. Adults with a shoulder out of its joint and who were not having surgery were asked to take part. All adults who were eligible and consented to take part were assigned, by chance, to either a single session of advice or the same session followed by physiotherapy. Between 14 November 2018 and 14 March 2022 we collected data on 482 people, from 41 NHS sites across the UK. We found at 6 months there was little evidence that additional physiotherapy was better, when compared to advice alone. Cost-effectiveness analysis (comparing changes in costs and quality of life) suggests additional physiotherapy might provide value for money. However, the changes involved are small and uncertain.

Comparisons of financial hardship in cancer care by family structure and among those with and without minor children using nationally representative data.

INTRODUCTION: While demographic risk factors of cancer-related financial hardships have been studied, having minor children or being single have rarely been assessed in the context of healthcare-related financial hardships. METHODS: Using data from the 2015 to 2018 National Health Interview Survey, we assessed financial hardship (material and psychological hardship; behavioral coping due to costs: delaying/foregoing care, reducing prescription costs, or skipping specialists or follow-up care) among adults aged 18-59 years with cancer (N = 2844) by minor child parenting status and family structure. In a secondary analysis, we compared this group with individuals without cancer. Using logistic regression models, we compared those with and without children aged <18 years, further distinguishing between those who were single versus one of two or more adults in the family. RESULTS: Compared to individuals from families with two or more adults/without children, single adults with children more often reported cancer-related financial hardships, for example material hardship (45.9% vs. 38.8%), and reducing prescription costs, (50.7% vs. 34.4%, adjusted OR 1.57, 95% CI 1.07-2.28). Single adults without minor children and those from families with two or more adults/with minor children also reported greater financial hardships on some dimensions. Associations were similar among those without cancer, but the overall magnitude of financial hardships was lower compared to those with cancer. CONCLUSIONS: Our findings suggest that having minor children, and being a single adult are risk factors for cancer-related financial hardship. Financial vulnerability associated with family structure should be taken into consideration in healthcare, and especially cancer care.

Postacute Care for Medicare Advantage Enrollees Who Switched to Traditional Medicare Compared With Those Who Remained in Medicare Advantage.

Importance: Medicare Advantage (MA) plans receive capitated per enrollee payments that create financial incentives to provide care more efficiently than traditional Medicare (TM); however, incentives could be associated with MA plans reducing use of beneficial services. Postacute care can improve functional status, but it is costly, and thus may be provided differently to Medicare beneficiaries by MA plans compared with TM. Objective: To estimate the association of MA compared with TM enrollment with postacute care use and postdischarge outcomes. Design, Setting, and Participants: This was a cohort study using Medicare data on 4613 hospitalizations among retired Ohio state employees and 2 comparison groups in 2015 and 2016. The study investigated the association of a policy change with use of postacute care and outcomes. The policy changed state retiree health benefits in Ohio from a mandatory MA plan to subsidies for either supplemental TM coverage or an MA plan. After policy implementation, approximately 75% of retired Ohio state employees switched to TM. Hospitalizations for 3 high-volume conditions that usually require postacute rehabilitation were assessed. Data from the Medicare Provider Analysis and Review files were used to identify all hospitalizations in short-term acute care hospitals. Difference-in-difference regressions were used to estimate changes for retired Ohio state employees compared with other 2015 MA enrollees in Ohio and with Kentucky public retirees who were continuously offered a mandatory MA plan. Data analyses were performed from September 1, 2019, to November 30, 2023. Exposures: Enrollment in Ohio state retiree health benefits in 2015, after which most members shifted to TM. Main Outcomes and Measures: Received care in an inpatient rehabilitation facility, skilled nursing facility, or home health, or any postacute care; the occurrence of any hospital readmission; the number of days in the community during the 30 days after hospital discharge; and mortality. Results: The study sample included 2373 hospitalizations for Ohio public retirees, 1651 hospitalizations for other Humana MA enrollees in Ohio, and 589 hospitalizations for public retirees in Kentucky. After the 2016 policy implementation, the percentage of hospitalizations covered by MA decreased by 70.1 (95% CI, -74.2 to -65.9) percentage points (pp), inpatient rehabilitation facility admissions increased by 9.7 (95% CI, 4.7 to 14.7) pp, use of only home health or skilled nursing facility care fell by 8.6 (95% CI, -14.6 to -2.6) pp, and days in the community fell by 1.6 (95% CI, -2.9 to -0.3) days for Ohio public retirees compared with other Humana MA enrollees in Ohio. There was no change in 30-day mortality or hospital readmissions; similar results were found by comparisons using Kentucky public retirees as a control group. Conclusions and Relevance: The findings of this cohort study indicate that after a change in retiree health benefits, most Ohio public retirees shifted from MA to TM and received more intensive postacute care with no significant change in measured short-term postdischarge outcomes. Future work should consider additional measures of postacute functional status over a longer follow-up period.

Acute rehabilitation following traumatic anterior shoulder dislocation (ARTISAN): pragmatic, multicentre, randomised controlled trial.

OBJECTIVE: To assess the effects of an additional programme of physiotherapy in adults with a first-time traumatic shoulder dislocation compared with single session of advice, supporting materials, and option to self-refer to physiotherapy. DESIGN: Pragmatic, multicentre, randomised controlled trial (ARTISAN). SETTING AND PARTICIPANTS: Trauma research teams at 41 UK NHS Trust sites screened adults with a first time traumatic anterior shoulder dislocation confirmed radiologically, being managed non-operatively. People were excluded if they presented with both shoulders dislocated, had a neurovascular complication, or were considered for surgical management. INTERVENTIONS: One session of advice, supporting materials, and option to self-refer to physiotherapy (n=240) was assessed against the same advice and supporting materials and an additional programme of physiotherapy (n=242). Analyses were on an intention-to-treat basis with secondary per protocol analyses. MAIN OUTCOME MEASURES: The primary outcome was the Oxford shoulder instability score (a single composite measure of shoulder function), measured six months after treatment allocation. Secondary outcomes included the QuickDASH, EQ-5D-5L, and complications. RESULTS: 482 participants were recruited from 40 sites in the UK. 354 (73%) participants completed the primary outcome score (n=180 allocated to advice only, n=174 allocated to advice and physiotherapy). Participants were mostly male (66%), with a mean age of 45 years. No significant difference was noted between advice compared with advice and a programme of physiotherapy at six months for the primary intention-to-treat adjusted analysis (between group difference favouring physiotherapy 1.5 (95% confidence interval -0.3 to 3.5)) or at earlier three month and six week timepoints. Complication profiles were similar across the two groups (P>0.05). CONCLUSIONS: An additional programme of current physiotherapy is not superior to advice, supporting materials, and the option to self-refer to physiotherapy. TRIAL REGISTRATION: Current Controlled Trials ISRCTN63184243.

Long-term multimorbidity trajectories in older adults: The role of cancer, demographics, and health behaviors.

BACKGROUND: Multimorbidity is associated with premature mortality and excess health care costs. The burden of multimorbidity is highest among patients with cancer, yet trends and determinants of multimorbidity over time are poorly understood. METHODS: Via Medicare claims linked to Cancer Prevention Study II data, group-based trajectory modeling was used to compare National Cancer Institute comorbidity index score trends for cancer survivors and older adults without a cancer history. Among cancer survivors, multinomial logistic regression analyses evaluated associations between demographics, health behaviors, and comorbidity trajectories. RESULTS: In 82,754 participants (mean age, 71.6 years [SD, 5.1 years]; 56.9% female), cancer survivors (n = 11,265) were more likely than older adults without a cancer history to experience the riskiest comorbidity trajectories: (1) steady, high comorbidity scores (remain high; odds ratio [OR], 1.36; 95% CI, 1.29-1.45), and (2) high scores that increased over time (start high and increase; OR, 1.51; 95% CI, 1.38-1.65). Cancer survivors who were physically active postdiagnosis were less likely to fall into these two trajectories (OR, 0.73; 95% CI, 0.64-0.84, remain high; OR, 0.42; 95% CI, 0.33-0.53, start high and increase) compared to inactive survivors. Cancer survivors with obesity were more likely to have a trajectory that started high and increased (OR, 2.83; 95% CI, 2.32-3.45 vs. normal weight), although being physically active offset some obesity-related risk. Cancer survivors who smoked postdiagnosis were also six times more likely to have trajectories that started high and increased (OR, 6.86; 95% CI, 4.41-10.66 vs. never smokers). CONCLUSIONS: Older cancer survivors are more likely to have multiple comorbidities accumulated at a faster pace than older adults without a history of cancer. Weight management, physical activity, and smoking avoidance postdiagnosis may attenuate that trend.

UK robotic arthroplasty clinical and cost effectiveness randomised controlled trial for hips (RACER-Hip): a study protocol.

INTRODUCTION: The number of robotic-assisted hip replacement procedures has expanded globally with the intended aim of improving outcomes. Intraoperative robotic-arm systems add additional costs to total hip replacement (THR) surgery but may improve surgical precision and could contribute to diminished pain and improved function. Additionally, these systems may reduce the need for expensive revision surgery. Surgery with conventional instruments may be just as successful, quick and affordable. There is timely demand for a robust evaluation of this technology. METHODS AND ANALYSIS: The Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial for Hips (RACER-Hip) is a multicentre (minimum of six UK sites), participant-assessor blinded, randomised controlled trial. 378 participants with hip osteoarthritis requiring THR will be randomised (1:1) to receive robotic-assisted THR, or THR using conventional surgical instruments. The primary outcome is the Forgotten Joint Score at 12 months post-randomisation; a patient-reported outcome measure assessing participants' awareness of their joint when undertaking daily activities. Secondary outcomes will be collected post-operatively (pain, blood loss and opioid usage) and at 3, 6, 12, 24 months, then 5 and 10 years postrandomisation (including function, pain, health-related quality of life, reoperations and satisfaction). Allocation concealment will be accomplished using a computer-based randomisation procedure on the day of surgery. Blinding methods include the use of sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will adhere to Consolidated Standards of Reporting Trials statements. ETHICS AND DISSEMINATION: The trial was approved by an ethics committee (Solihull Research Ethics Committee, 30 June 2021, IRAS: 295831). Participants will provide informed consent before agreeing to participate. Results will be disseminated using peer-reviewed journal publications, presentations at international conferences and through the use of social media. We will develop plans to disseminate to patients and public with our patient partners. TRIAL REGISTRATION NUMBER: ISRCTN13374625.

Evaluation of the Completeness of Managed Care Data to Identify Cancer Diagnoses and Treatments for Patients in the SEER-Medicare Data.

BACKGROUND: The utility of codes on Medicare Advantage (MA) data to capture cancer diagnoses and treatment for cancer patients is unknown. OBJECTIVE: This study compared cancer diagnoses and treatments on MA encounter data (MA data) with the Surveillance, Epidemiology, and End-Results (SEER) data. SUBJECTS: Subjects were patients enrolled in either MA or Medicare fee-for-service (MFFS) when diagnosed with incident breast, colorectal, prostate, or lung cancer, 2015-2017, in a SEER cancer registry. MEASURES: MA data, from 2 months before to 12 months following SEER diagnosis, were reviewed to identify cancer diagnoses, surgery, chemotherapy, and radiotherapy (RT). MA data were compared with SEER to determine their sensitivity to capture cancer diagnoses and sensitivity/specificity to identify surgeries. The agreement between SEER and Medicare data regarding receipt of chemotherapy and RT was measured by Kappa statistics. A similar comparison to SEER diagnoses/treatments was made using MFFS claims to provide context for the SEER-MA comparison. RESULTS: The study included 186,449 patients, 38% in MA. MA data had 92%+ sensitivity to identify SEER cancer diagnosis and 90%+ sensitivity for cancer surgery. Specificity for surgery was >84%, except for breast cancer (52%). Kappa statistics for agreement between SEER and MA data regarding chemotherapy varied by cancer, 0.61-0.82, and for receipt of RT exceeded 0.75 for all cancers. Results observed for MFFS claims were similar to those in MA data. CONCLUSION: For 4 common cancers, MA data included most cancer diagnoses and general types of cancer treatment reported in the SEER data. More research is needed to assess additional cancers and detailed treatments.

Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocol.

INTRODUCTION: Robotic-assisted knee replacement systems have been introduced to healthcare services worldwide in an effort to improve clinical outcomes for people, although high-quality evidence that they are clinically, or cost-effective remains sparse. Robotic-arm systems may improve surgical accuracy and could contribute to reduced pain, improved function and lower overall cost of total knee replacement (TKR) surgery. However, TKR with conventional instruments may be just as effective and may be quicker and cheaper. There is a need for a robust evaluation of this technology, including cost-effectiveness analyses using both within-trial and modelling approaches. This trial will compare robotic-assisted against conventional TKR to provide high-quality evidence on whether robotic-assisted knee replacement is beneficial to patients and cost-effective for healthcare systems. METHODS AND ANALYSIS: The Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial-Knee is a multicentre, participant-assessor blinded, randomised controlled trial to evaluate the clinical and cost-effectiveness of robotic-assisted TKR compared with TKR using conventional instruments. A total of 332 participants will be randomised (1:1) to provide 90% power for a 12-point difference in the primary outcome measure; the Forgotten Joint Score at 12 months postrandomisation. Allocation concealment will be achieved using computer-based randomisation performed on the day of surgery and methods for blinding will include sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will be reported in line with the Consolidated Standards of Reporting Trials statement. A parallel study will collect data on the learning effects associated with robotic-arm systems. ETHICS AND DISSEMINATION: The trial has been approved by an ethics committee for patient participation (East Midlands-Nottingham 2 Research Ethics Committee, 29 July 2020. NRES number: 20/EM/0159). All results from the study will be disseminated using peer-reviewed publications, presentations at international conferences, lay summaries and social media as appropriate. TRIAL REGISTRATION NUMBER: ISRCTN27624068.

Cost of Cancer in Adolescents and Young Adults in the United States: Results of the 2021 Report by Deloitte Access Economics, Commissioned by Teen Cancer America.

PURPOSE: The purpose of this report, commissioned by Teen Cancer America and performed by Deloitte Access Economics in 2021, was to estimate the total costs incurred by adolescent and young adults (AYAs) after cancer diagnosis in the United States (US) over their life course. METHODS: The incidence of cancer in 2019 among AYAs age 15-39 years was estimated from the US Cancer Statistics Public Use Database, and relative survival was projected from the Surveillance, Epidemiology, and End Results Program. Cost domains included health system, productivity, and well-being costs. Components were estimated with published literature and pooled data from the Medical Expenditure Panel Survey from 2008 to 2012 and inflated to 2019 dollars. RESULTS: The economic and human costs of cancer in AYAs are substantial-$23.5 billion overall, corresponding to $259,324 per person over the lifetime. The majority of costs are borne by AYA cancer survivors themselves in the form of lost productivity, loss of well-being, and loss of life. CONCLUSION: These findings underscore the need to address the burden of cancer in AYAs through targeted programs for AYAs, such as financial navigation and health insurance literacy interventions, as well as local and national policy initiatives to address access to and enhanced coverage for clinical trials participation, fertility services, and survivorship care.

Impact of a pre-existing diagnosis of mental illness on stage of breast cancer diagnosis among older women.

PURPOSE: Having a mental illness increases risk of mortality for women with breast cancer, partly due to barriers to accessing recommended care (e.g., cancer screening). Early detection is one important factor in breast cancer survival. To further understand this disparity in survival, we examined whether older women with mental illness are more likely to be diagnosed with later-staged breast cancers compared to women without mental illnesses. METHODS: We used 2005-2015 SEER-Medicare data to identify AJCC stage I-IV breast cancer patients with and without a history of mental illness prior to cancer diagnosis. We used generalized ordinal regression to examine associations between mental illness diagnoses and stage at diagnosis, controlling for age, race/ethnicity, income, comorbidities, primary care use, rurality, and marital status. RESULTS: Among 96,034 women with breast cancer, 1.7% have a serious mental illness (SMI), 19.9% depression or anxiety, and 7.0% other mental illness. Those with SMI have 40% higher odds of being diagnosed with AJCC Stages II, III than Stage I; women with depression/anxiety have 25% lower odds of being diagnosed with Stage IV cancer than Stage I; and women with other mental illnesses have similar odds of being diagnosed in later stages. CONCLUSION: Women with SMI have higher odds of being diagnosed at later stages, which likely contributes to higher mortality after breast cancer. Surprisingly, women with depression and anxiety have a lower risk of being diagnosed with Stage IV cancer. Earlier breast cancer diagnosis in women with SMI is an important goal for reducing disparities breast cancer survival.

Fracture Risk Among Older Cancer Survivors Compared With Older Adults Without a History of Cancer.

Importance: The number of cancer survivors living in the US is projected to be 26.1 million by 2040. Cancer survivors may be at increased risk of bone fractures, but research is limited in several important ways. Objective: To investigate the associations of cancer diagnoses, including time since diagnosis and stage at diagnosis, with risks of pelvic, radial, and vertebral fractures (separately and combined) among older cancer survivors and compared with fracture risk among older adults without a history of cancer. Secondarily, to examine differences in risk of fracture stratified by modifiable behaviors, treatment, and cancer type. Design, Setting, and Participants: This longitudinal cohort study used data from 92 431 older adults in the US Cancer Prevention Study II Nutrition Cohort linked with 1999 to 2017 Medicare claims. Data were analyzed from July 15, 2021, to May 3, 2022. Exposures: Cancer history, time since cancer diagnosis, and stage at cancer diagnosis. Main Outcomes and Measures: Hazard ratios (HRs) and 95% CIs for the risk of pelvic, radial, vertebral, and total frailty-related fractures were estimated using multivariate Cox proportional hazards regression. Stratification was used for secondary aims. Results: Among 92 431 participants (mean [SD] age, was 69.4 [6.0] years, 51 820 [56%] women, and 90 458 [97.9%] White], 12 943 participants experienced a frailty-related bone fracture. Compared with participants without a history of cancer, cancer survivors who were diagnosed 1 to less than 5 years earlier with advanced stage cancer had higher risk of fracture (HR, 2.12; 95% CI, 1.75-2.58). The higher fracture risk in cancer survivors with recent advanced stage diagnosis (vs no cancer) was driven largely by vertebral (HR, 2.46; 95% CI, 1.93-3.13) and pelvic (HR, 2.46; 95% CI, 1.84-3.29) fracture sites. Compared with cancer survivors who did not receive chemotherapy, survivors who received chemotherapy were more likely to have a fracture; this association was stronger within 5 years of diagnosis (HR, 1.31; 95% CI, 1.09-1.57) than 5 or more years after diagnosis (HR, 1.22; 95% CI, 0.99-1.51). Although the HR for risk of fracture was lower among physically active cancer survivors 5 or more years after diagnosis (HR, 0.76; 95% CI, 0.54-1.07), this result was not statistically significant, whereas current smoking was significantly associated with higher risk of fracture (HR, 2.27; 95% CI, 1.55-3.33). Conclusions and Relevance: Findings from this cohort study suggest that older adults with a history of cancer may benefit from clinical guidance on prevention of frailty-related fractures. If study findings are replicated, fracture prevention programs for survivors might include referrals for physical activity with cancer exercise professionals and smoking cessation programs.

Group sequential designs in pragmatic trials: feasibility and assessment of utility using data from a number of recent surgical RCTs.

BACKGROUND: Assessing the long term effects of many surgical interventions tested in pragmatic RCTs may require extended periods of participant follow-up to assess effectiveness and use patient-reported outcomes that require large sample sizes. Consequently the RCTs are often perceived as being expensive and time-consuming, particularly if the results show the test intervention is not effective. Adaptive, and particularly group sequential, designs have great potential to improve the efficiency and cost of testing new and existing surgical interventions. As a means to assess the potential utility of group sequential designs, we re-analyse data from a number of recent high-profile RCTs and assess whether using such a design would have caused the trial to stop early. METHODS: Many pragmatic RCTs monitor participants at a number of occasions (e.g. at 6, 12 and 24 months after surgery) during follow-up as a means to assess recovery and also to keep participants engaged with the trial process. Conventionally one of the outcomes is selected as the primary (final) outcome, for clinical reasons, with others designated as either early or late outcomes. In such settings, novel group sequential designs that use data from not only the final outcome but also from early outcomes at interim analyses can be used to inform stopping decisions. We describe data from seven recent surgical RCTs (WAT, DRAFFT, WOLLF, FASHION, CSAW, FIXDT, TOPKAT), and outline possible group sequential designs that could plausibly have been proposed at the design stage. We then simulate how these group sequential designs could have proceeded, by using the observed data and dates to replicate how information could have accumulated and decisions been made for each RCT. RESULTS: The results of the simulated group sequential designs showed that for two of the RCTs it was highly likely that they would have stopped for futility at interim analyses, potentially saving considerable time (15 and 23 months) and costs and avoiding patients being exposed to interventions that were either ineffective or no better than standard care. We discuss the characteristics of RCTs that are important in order to use the methodology we describe, particularly the value of early outcomes and the window of opportunity when early stopping decisions can be made and how it is related to the length of recruitment period and follow-up. CONCLUSIONS: The results for five of the RCTs tested showed that group sequential designs using early outcome data would have been feasible and likely to provide designs that were at least as efficient, and possibly more efficient, than the original fixed sample size designs. In general, the amount of information provided by the early outcomes was surprisingly large, due to the strength of correlations with the primary outcome. This suggests that the methods described here are likely to provide benefits more generally across the range of surgical trials and more widely in other application areas where trial designs, outcomes and follow-up patterns are structured and behave similarly.

Cost-utility analysis of cast compared to removable brace in the management of adult patients with ankle fractures.

AIMS: To compare the cost-utility of removable brace compared with cast in the management of adult patients with ankle fracture. METHODS: A within-trial economic evaluation conducted from the UK NHS and personnel social services (PSS) perspective. Health resources and quality-of-life data were collected as part of the Ankle Injury Rehabilitation (AIR) multicentre, randomized controlled trial over a 12-month period using trial case report forms and patient-completed questionnaires. Cost-utility analysis was estimated in terms of the incremental cost per quality adjusted life year (QALY) gained. Estimate uncertainty was explored by bootstrapping, visualized on the incremental cost-effectiveness ratio plane. Net monetary benefit and probability of cost-effectiveness were evaluated at a range of willingness-to-pay thresholds and visualized graphically. RESULTS: The incremental cost and QALYs of using brace over a 12-month period were £46.73 (95% confidence interval (CI) £-9 to £147) and 0.0141 (95% CI -0.005 to 0.033), respectively. The cost per QALY gained was £3,318. The probability of brace being cost-effective at a £30,000 per QALY willingness-to-pay threshold was 88%. The results remained robust to a range of sensitivity analyses. CONCLUSION: This within-trial economic evaluation found that it is probable that using a removable brace provides good value to the NHS when compared to cast, in the management of adults with ankle fracture. Cite this article: Bone Jt Open 2022;3(6):455-462.

Opportunities for personalizing colorectal cancer care: an analysis of SEER-medicare data.

United States clinical practice guidelines for metastatic colorectal cancer recommend use of medications impacted by genetic variants but do not recommend testing. We analyzed real-world treatment using a cancer registry and claims dataset to explore pharmacogenomic (PGx) medication treatment patterns and characterize exposure. In a cohort of 6957 patients, most (86.9%) were exposed to at least one chemotherapy medication with PGx guidelines. In a cohort of 2223 patients with retail pharmacy claims available, most (79.2%) were treated with at least one non-chemotherapy (79.2%) medication with PGx guidelines. PGx-associated chemotherapy exposure was associated with age, race/ethnicity, educational attainment, and rurality. PGx-associated non-chemotherapy exposure was associated with medication use and comorbidities. The potential impact of PGx testing is large and policies aimed at increasing PGx testing at diagnosis may impact treatment decisions for patients with metastatic colorectal cancer as most patients are exposed to medications with pharmacogenomics implications during treatment.

Forgoing physician visits due to cost: regional clustering among cancer survivors by age, sex, and race/ethnicity.

BACKGROUND: Innovative treatments have improved cancer survival but also increased financial hardship for patients. While demographic factors associated with financial hardship among cancer survivors are known in the USA, the role of geography is less clear. METHODS: We evaluated prevalence of forgoing care due to cost within 12 months by US Census region (Northeast, North Central/Midwest [NCMW], South, West) by demographic factors (age, sex, race/ethnicity) among 217,981 cancer survivors aged 18 to 82 years from the 2015-2019 Behavioral Risk Factor Surveillance System survey. We summarized region- and group-specific prevalence of forgoing physician visits due to cost and used multilevel logistic regression models to compare regions. RESULTS: The prevalence of forgoing physician visits due to cost was highest in the South (aged < 65 years: 19-38%; aged ≥ 65: 4-21%; adjusted odds ratios [OR], NCMW versus South, OR: 0.63 [0.56-0.71]; Northeast versus South, OR: 0.63 [0.55-0.73]; West versus South, OR: 0.73 [0.64-0.84]). Across the USA, including regions with broad Medicaid expansion, younger, female, and persons of color most often reported cost-related forgoing physician visits. CONCLUSION: Forgoing physician visits due to cost among cancer survivors is regionally clustered, raising concerns for concentrated poor long-term cancer outcomes. Underlying factors likely include variation in regional population compositions and contextual factors, such as Medicaid expansion and social policies. Disproportionate cost burden among survivors of color in all regions highlight systemic barriers, underscoring the need to improve access to the entire spectrum of care for cancer survivors, and especially for those most vulnerable.

Workforce Caring for Cancer Survivors in the United States: Estimates and Projections of Use.

BACKGROUND: This study aims to quantify the extent and diversity of the cancer care workforce, beyond medical oncologists, to inform future demand because the number of cancer survivors is expected to grow in the United States. METHODS: Surveillance, Epidemiology, and End Results-Medicare data were used to evaluate health-care use of cancer survivors diagnosed between 2000 and 2014, enrolled in fee-for-service Medicare Parts A and B, and 65 years or older in 2008-2015. We calculated percentage of cancer survivors who saw each clinician specialty and their average annual number of visits in each phase of care. We projected the national number of individuals receiving care and number of annual visits by clinician specialty and phase of care through 2040. RESULTS: Cancer survivors had higher care use in the first year after diagnosis and last year of life phases. During the initial year after cancer diagnosis, most survivors were seen for cancer-related care by a medical oncologist (59.1%), primary care provider (55.9%), and/or other cancer-treating physicians (42.2%). The percentage of survivors with cancer-related visits to each specialty declined after the first year after diagnosis, plateauing after year 6-7. However, at 10 or more years after diagnosis, approximately 20% of cancer survivors had visits to medical oncologists and an average of 4 visits a year. CONCLUSIONS: Cancer survivors had higher care use in the first year after diagnosis and last year of life. High levels of care use across specialties in all phases of care have important implications for models of survivorship care coordination and workforce planning.

Trends in Patch Testing in the Medicare Part B Fee-for-Service Population.

BACKGROUND: Patch testing is a vital component of the workup for allergic contact dermatitis. There are limited data on changes of patch testing use among Medicare providers, as well as patch testing reimbursement rates. OBJECTIVE: The aim of the study was to evaluate trends in the use of patch testing among various Medicare providers and Medicare patch testing reimbursement. DESIGN: A longitudinal analysis of patch testing claims was performed with the Medicare Part B Physician/Supplier Procedure Summary files from 2010 to 2018. The primary outcomes were the total number and change in the number of submitted patch testing services from 2010 to 2018 by 3 provider groups: dermatology physicians, nondermatology physicians, and nonphysician providers. Secondary outcome measures included Medicare reimbursement amounts and changes in reimbursement amounts for patch test services (total and per 1000 enrollees) from 2010 to 2018 for the 3 provider groups, as well as per patch test service. RESULTS: From 2010 to 2018, submitted patch testing services per 1000 enrollees grew by 89.0%. The annual trend estimate for submitted services relative to 2010 was +10.1% (95% confidence interval [CI] = 8.1 to 12.0) for physicians and +34.1% (95% CI = 32.1 to 36.0) for nonphysician providers (physician assistants and nurse practitioners). Among physicians, the annual trend estimate for submitted services was +5.1% (95% CI = -11.3 to 21.5) for dermatologists and +31.40% (95% CI = 15.00 to 47.81) for allergists. CONCLUSIONS: Patch testing increased in the US Medicare population from 2010 to 2018, and this increase was largely driven by nonphysician providers and allergists.

Financial Burden of Drugs Prescribed for Cancer-Associated Symptoms.

PURPOSE: The financial toxicity of anticancer drugs is well-documented, but little is known about the costs of drugs used to manage cancer-associated symptoms. METHODS: We reviewed relevant guidelines and compiled drugs used to manage seven cancer-associated symptoms (anorexia and cachexia, chemotherapy-induced peripheral neuropathy, constipation, diarrhea, exocrine pancreatic insufficiency, cancer-associated fatigue, and chemotherapy-induced nausea and vomiting). Using GoodRx website, we identified the retail price (cash price at retail pharmacies) and lowest price (discounted, best-case scenario of out-of-pocket costs) for patients without insurance for each drug or formulation for a typical fill. We describe lowest prices here. RESULTS: For anorexia and cachexia, costs ranged from $5 US dollars (USD; generic olanzapine or mirtazapine tablets) to $1,156 USD (brand-name dronabinol solution) and varied widely by formulation of the same drug or dosage: for olanzapine 5 mg, $5 USD (generic tablet) to $239 USD (brand-name orally disintegrating tablet). For chemotherapy-induced peripheral neuropathy, costs of duloxetine varied from $12 USD (generic) to $529 USD (brand-name). For constipation, the cost of sennosides or polyethylene glycol was <$15 USD, whereas newer agents such as methylnaltrexone were expensive ($1,001 USD). For diarrhea, the cost of generic loperamide or diphenoxylate-atropine tablets was <$15 USD. For exocrine pancreatic insufficiency, only brand-name formulations were available, range of cost, $1,072 USD-$1,514 USD. For cancer-associated fatigue, the cost of generic dexamethasone or dexmethylphenidate was <$15 USD, whereas brand-name modafinil was more costly ($1,284 USD). For a 4-drug nausea and vomiting prophylaxis regimen, costs ranged from $181 USD to $1,430 USD. CONCLUSION: We highlight the high costs of many symptom control drugs and the wide variation in the costs of these drugs. These findings can guide patient-clinician discussions about cost-effectively managing symptoms, while promoting the use of less expensive formulations when possible.

The influence of the Affordable Care Act-Dependent Care Expansion on insurance coverage among young cancer survivors in California: an updated analysis.

PURPOSE: To assess changes in health insurance coverage for young cancer patients pre- and post- the Affordable Care Act-Dependent Care Expansion (ACA-DCE) implementation in California. Further, we examined differences in insurance coverage by socioeconomic and race/ethnicity. METHODS: Data were obtained from the California Cancer Registry and Medicaid enrollment files, from 2005 to 2014. We conducted difference-in-difference analyses among 7042 cancer patients aged 22-25 years ("intervention group") and 25,269 aged 26-34 years ("control group"). We also examined the independent and combined effects of race/ethnicity and neighborhood socioeconomic status (nSES) on insurance coverage. RESULTS: After the ACA-DCE implementation, we observed a 52.7% reduction in the proportion of uninsured and a 35.7% increase in the proportion of privately insured patients. There was also a 17.3% reduction in Medicaid at cancer diagnosis and a 27.5% reduction in discontinuous Medicaid enrollment. However, these benefits were limited to patients of non-Hispanic White, Hispanic and Asian/Pacific Islander race/ethnicity living in higher nSES, with no differences in insurance enrollment among young adults who lived in low nSES or those of Black race/ethnicity. CONCLUSION: The ACA-DCE broadened insurance coverage for young adults with cancer in California. Yet, only certain subgroups of patients have benefited from this policy.